A New Nonprescription Product for Overactive Bladder in Women

US Pharm. 2013;38(8):8-11.

Occasionally, the nonprescription product market undergoes a significant change. There is no greater change than the debut of a new product labeled to treat a medical condition that has never before been judged amenable to self-care. The September 2013 introduction of Oxytrol For Women (oxybutynin transdermal system) to the nonprescription product market is a perfect example of an Rx-to-OTC switch that could alter the health care habits of countless women.^1,2

Overactive Bladder

Overactive bladder (OAB) is also known as urinary incontinence.³ In classical OAB, bladder muscles are overactive. Patients with little or no urine in the bladder may feel a strong urge to urinate (urge incontinence), often along with nocturia.^3-5

OAB exists on a range of severity. When some OAB patients lose bladder control, they only notice a mild leakage that cannot be stopped. However, patients with a more severe form of OAB may experience uncontrolled voiding. More severe OAB can decrease the patient’s quality of life, increase the risk of depression, and reduce productivity at work.⁴

Some women experience a different type of bladder problem that also results in incontinence. They have weak bladder muscles that cannot hold urine back when they cough, sneeze, laugh, or lift a heavy object. This is not OAB, but is known as stress incontinence.^3,6

Prevalence and Epidemiology of OAB

As many as 17% to 40% of adult women in the United States have OAB.^4,7 This is approximately 20 million OAB patients. However, the true number is likely to be far higher, as many patients do not enter the health care system. There are three major reasons for this reluctance to do so.⁴ First, many patients view OAB as an inevitable part of aging and choose to take various self-care measures rather than visit a physician for advice. Second, as many as 61% of OAB sufferers do not realize that the condition can be successfully treated with medication and therefore do not seek help. Finally, OAB can induce shame and embarrassment in patients, and the resultant negative social stigma may cause them to avoid any mention to health care providers.

Although OAB occurs in women of all ages, it exhibits a strong age association.^3,8 The median age is 52 years, and the most common age range is 45 to 60 years.⁴

Coping Methods and Quality of Life Issues

Most women visit their physicians without hesita-tion for such conditions as urinary tract infections (UTIs), vaginal fungal infections, and birth control. However, for some inexplicable reason, a large number of those suffering from OAB postpone a medical appointment, many for as long as 6 or 7 years.⁴ During this time, they employ a variety of coping mechanisms of dubious efficacy and questionable safety. For instance, the use of absorbent pads is partially effective, but increases the risk of a UTI.⁴ Some women also take great pains to ascertain the location of all bathrooms in advance of an attack of OAB, a behavior known as toilet mapping.⁴

Women with symptoms of OAB may reduce the extent of activities they once found pleasurable, such as movies, walks, tennis, golf, or visiting with friends. They may voluntarily reduce fluid intake, which can lead to dehydration. They may feel forced to wear clothing that would conceal a urine leak, and only sit on furniture that would not be permanently stained if a leak were to occur. It becomes apparent that OAB can cause constant concern due to fear of an accident and also the perception that odor from underclothing or absorbent pads might be detected by others. If a patient feels forced to lead a more sedentary lifestyle, she may experience greater medical and psychological problems.

Oxytrol For Women

Oxybutynin is an anticholinergic and antispasmodic agent that has been available in oral form since 1976 (originally as Ditropan) and in a topical patch form on a prescription basis since 2003.^4,9 It relaxes bladder smooth muscle cells, which increases the maximum capacity of the bladder and also increases the volume to which the bladder fills before the patient begins to experience contractions of the detrusor muscle. The FDA approval of nonprescription Oxytrol For Women (oxybutynin transdermal system, 3.9 mg/day) marks the first time that women can purchase a nonprescription product for OAB. The product is identical to the prescription Oxytrol Patch.⁴

As with any newly released non-prescription product, pharmacists must take extra care in examining the label closely to understand all of the FDA-required safe conditions for use.⁴ Each patch contains a total of 36 mg of oxybutynin, delivering 3.9 mg of oxybutynin daily. The label instructs potential purchasers that they may have OAB if they experience two or more of the following symptoms for at least 3 months: 1) urinary frequency (a need to urinate more often than normal, especially more than 8 times in 24 hours); 2) urinary urgency (strong and immediate need to urinate); and/or 3) urge incontinence (leaking or wetting if the urge to urinate cannot be controlled). The label warns that frequent urination may also be caused by a UTI, diabetes, early pregnancy, or other more serious conditions, and urges the woman to see a physician if she thinks that any of those conditions are present.

The label cautions against use in the following situations: male gender; under the age of 18 years; allergy to oxybutynin; narrow-angle glaucoma; symptoms of a UTI or other serious condition for which patients should see a physician immediately (e.g., pain or burning when urinating, accompanied by fever or chills); blood in the urine; unexplained lower back or side pain; urine that is cloudy or foul smelling; urine loss only when the patient coughs, sneezes, or laughs (since the product is not effective for stress incontinence); and present diagnosis of urinary retention or gastric retention.⁴

Patients are urged to ask a physician before using Oxytrol For Women if they have risk factors or symptoms of diabetes (e.g., a history of diabetes in the immediate family, excessive thirst, extreme hunger, increasing tiredness), unexplained weight loss, a history of kidney stones, or liver or kidney disease.⁴ They should also speak to a health professional before use if they are pregnant or breast-feeding. Labels warn patients to speak to a physician or pharmacist before use if they are already taking a prescription medication for OAB or a diuretic.

Patients are warned that, when using the product, they may notice mild redness when the patch is removed, which usually abates after a few hours. They may also notice sleepiness, dizziness, or blurred vision. Ingestion of alcohol may worsen the drowsiness. Users are cautioned to be careful when driving a vehicle or operating machinery.⁴

Patients are cautioned to stop use and ask a physician if they are not able to empty the bladder; if the condition worsens or new symptoms appear; if the condition does not improve after 2 weeks of use; if they experience an allergic reaction to the product; or if they have severe redness, itchiness, or blistering at the site of application.⁴

To use Oxytrol For Women, patients should open a patch and apply it immediately to a clean, dry, and smooth area of skin on the abdomen, hips, or buttocks. They should avoid oily, damaged (cut or scraped), or irritated skin (e.g., with an active rash). They should not place patches on skin that is treated with lotions, powders, or oils, as the patch may not adhere to those areas. They should wear the patch under clothing, avoiding areas exposed to sunlight. Patches should be applied whole and not cut into pieces. Patients should wear only one patch at a time, for 4 consecutive days, after which they remove and discard the used patch and apply a new one. They should continue to change the patch every 4 days, rotating application sites each time to reduce the risk of skin irritation. To dispose of a used patch, they should fold the sticky sides together and discard the patch where it cannot be retrieved and ingested by a child or pet.⁴

Other Useful Counseling Information

The pharmacist should be familiar with other useful information regarding Oxytrol For Women that is not required on the nonprescrip-tion product label.⁴ For instance, patients using anticholinergics such as oxybutynin should be warned not to enter hot environments, since that group of medications reduces the ability to sweat, and the wearer may suffer heat prostration, with fever and heat stroke. Oral dosage forms of oxybutynin have caused angioedema,⁴ and patients should be informed that the appearance of any symptoms that might be angioedema is sufficient cause for a 911 call, with immediate transport to an emergency room.

The label warning against use in gastric retention is required because anticholinergics decrease gastric motility.⁴ However, the label omits other examples of patients who are at high risk of complications due to decreased gastric motility, such as those with ulcerative colitis, intestinal atony, and myasthenia gravis. It is also vital to know that patients with gastroesophageal reflux should use Oxytrol For Women with caution, a warning that also includes patients who are taking bisphosphonates (e.g., alendronate, ibandronate, risedronate), since these drugs can induce or worsen reflux.⁴

Patients purchasing Oxytrol For Women should be warned that it might induce other adverse reactions not listed on the label.⁴ These include application site abnormalities (rash, macules, pruritus, or burning), back pain, dry mouth, constipation, nausea, abdominal pain, flatulence, fatigue, headache, flushing, or diffuse rash. Most of these events are mild or moderate in severity.

To facilitate compliance, patients can be instructed to change patches on the same 2 days each week. Product packages have a calendar on the back to help patients remember when changing is due.⁴

Water may come into contact with the patch during routine activities such as swimming, bathing, showering, or exercising. This does not affect the patch. However, the manufacturer cautions patients not to rub the patch area when carrying out those activities.⁴

It is predictable that men will ask about using Oxytrol For Women for their OAB. The problem is that their symptoms may be due to prostate problems, so a prostate examination is required to rule out more serious conditions. For this reason, men should be strongly discouraged from using the product and urged to visit their physician for a differential diagnosis regarding the etiology of their OAB symptoms.

PATIENT INFORMATION

What Is Overactive Bladder?

Normally, your urinary tract functions quite well. Your kidneys produce urine that is stored in the bladder, and your bladder is relaxed when there is no urine present. As your bladder fills with urine, your nerves send a signal that it needs to be emptied. When you have overactive bladder, the signals to empty the bladder are sent even though the bladder is not full. As a result, you may notice the following: 1) you feel the need to urinate 8 or more times during the day, and 2 or more times during a typical night; 2) you feel a sudden, strong, and immediate urge to urinate; and 3) you leak urine uncontrollably after you have the sudden and strong urge to urinate. Further, when you attempt to urinate, there is often very little urine or no urine at all.

Overactive bladder is not the same as stress incontinence. With stress incontinence, you leak urine when sneezing, laughing, or carrying out other physical activities.

Who Is Likely to Have Overactive Bladder?

Overactive bladder is more common with aging, in both men and women. Women past the age of menopause and men with prostate problems are at greater risk, as are patients with a history of stroke or multiple sclerosis.

How Can Diet Affect Overactive Bladder?

Some foods and drinks irritate the bladder, possibly contributing to the problem. You should strive to eliminate caffeine from your diet by halting use of coffee, tea, and all caffeinated soft drinks. Alcohol should be eliminated entirely, as it is another bladder irritant. Spices such as pepper add flavor to foods, but they also can cause severe irritation to the bowels and bladder. It may be helpful to keep a diary of your intake of these foods and drinks to see if they actually do produce a worsening of symptoms.

A New Nonprescription Product

Women may try the behavioral changes mentioned above, as well as one of several prescription medications (e.g., Ditropan, Detrol, Toviaz, Vesicare) that relax the muscles of the bladder to prevent contractions. Physicians may also attempt such therapies as application of electrical impulses or Botox.

A new nonprescription product may be helpful for overactive bladder. It is known as Oxytrol For Women, which is available as a patch that is worn continuously on the skin for 4 days and contains the medication oxybutynin.

This product may be appropriate for you if you have had two or more of the following symptoms (as described above) for at least 3 months: 1) urinary frequency, more than 8 times in 24 hours; 2) urinary urgency; and 3) urge incontinence. However, urinary frequency can also be caused by urinary tract infections, diabetes, pregnancy (in the early stages), and other more serious conditions. If you think you have any of these, you should see a physician instead.

The product’s label will have many additional use precautions, warnings, and instructions. You should read and heed each of these. Further, it is wise to Consult Your Pharmacist for additional assistance regarding use of this innovative new approach to overactive bladder.

Remember, if you have questions, Consult Your Pharmacist.

REFERENCES

1. Merck: FDA approves Oxytrol for Women, creating overactive bladder category in OTC. Drug Store News. January 25, 2013. http://drugstorenews.com/article/merck-fda-approves-oxytrol-women-creating-overactive-bladder-category-otc. Accessed June 24, 2013.
2. Schiff D. Merck’s Oxytrol could be OTC trailblazer for chronic conditions. The Tan Sheet. March 11, 2013. http://usciencesblogs.typepad.com/files/t130311_oxytrol_otc_trailblazer.pdf. Accessed June 24, 2013.
3. Urinary incontinence. MedlinePlus. www.nlm.nih.gov/medlineplus/urinaryincontinence.html. Accessed June 24, 2013.
4. Oxytrol For Women (oxybutynin transdermal system, 3.9 mg/day). FDA advisory committee briefing document. Merck Consumer Care. November 9, 2012. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UCM327162.pdf. Accessed June 24, 2013.
5. What I need to know about bladder control for women. National Institute of Diabetes and Digestive and Kidney Diseases. http://kidney.niddk.nih.gov/kudiseases/pubs/bcw_ez/. Accessed June 24, 2013.
6. Overactive bladder. MedlinePlus. www.nlm.nih.gov/medlineplus/overactivebladder.html. Accessed June 24, 2013.
7. Overactive bladder (OAB). Urology Care Foundation. www.urologyhealth.org/urology/index.cfm?article=112. Accessed June 24, 2013.
8. Urgency urinary incontinence/overactive bladder. National Association for Continence. www.nafc.org/bladder-bowel-health/types-of-incontinence/urge-incontinence/. Accessed June 24, 2013.
9. Evaluating prescription drugs used to treat overactive bladder. Consumer Reports. 2010. www.consumerreports.org/health/resources/pdf/best-buy-drugs/Overactive_Bladder-FINAL.pdf. Accessed June 24, 2103.
10. Oxytrol For Women. Merck Consumer Care. www.oxytrolforwomen.com. Accessed July 8, 2013.

To comment on this article, contact rdavidson@uspharmacist.com.